1. Field of the Invention
The present invention relates to devices for medical catheters for minimizing or preventing catheter related infection, and more particularly to a slidable and attachable catheter device that can be impregnated with silver ion, and/or contain and disperse an antiseptic substance such as silver sulfadiazine, or other suitable substance, for substantially reducing the incidence of catheter-related infection caused by colonization of bacteria or fungi around the point of catheter insertion with probable entry in to the tissues, or blood stream, at the catheter insertion site.
2. Description of the Background Art
The use of urethral catheters for draining bodily fluids and irrigation is well known in the art. It has been found that the rate of bacterial infection, associated with urethral catheterization, rises sharply in patients requiring prolonged catheter insertion, as is often necessary. Similar infection complications are also experienced with percutaneously inserted catheters and I.V. tubes. Likewise, the use of fluid drains for draining infectious or non-infectious fluids, or for blood or serum collection result in similar bacterial infection problems.
While it is possible for infectious bacteria to invade the body through catheter tubing lumen channels, a strong correlation has been shown between organisms colonizing skin at the insertion site and microorganisms causing catheter-related infection. It has been found that organisms penetrate from the site of catheter insertion around the outside of the catheter lumen into deeper tissues, or, in the case of venous catheters, directly into the blood stream. As a result, physicians routinely suppress the microorganism population around the catheter insertion site with an effective antiseptic prior to catheterization. However, it has been found that certain suppressed microorganisms grow back at a rapid rate leading to infection originating at the catheterization site.
With urethral catheters bacterial infection may occur in association with single or multiple catheterizations. With retention catheters bacterial infections rise precipitously, and it has been found that approximately 98 percent of patients experience bacterial infection within four days. Kass, E. H. and Sossen: A Report on the Prevention of Infection of the Urinary Tract in the Presence of Indwelling Catheters, Journal of the American Medical Association; 169:1181, 1959. With closed drainage systems, in which there is no manipulation, handling, or irrigation through the catheter lumens, infections have been found to occur later--within approximately ten days. These infections can lead to infections of the bladder, renal inflammation, ascending infection of the kidneys, and septicemia. Accordingly, studies have shown that infections can arise through the catheter lumen or from outside the catheter in the space between the catheter wall and the urethra. Kass, E. H. and Schneiderman, L. J., Entry of Bacteria into the Urinary Tract of Patients with indwelling Catheters, New England Journal of Medicine; 256:556, 1957. Since urethral secretions provide an excellent culture medium for bacterial growth, the inventor herein, has devised a catheter that allows for retrograde irrigation with antiseptic solutions to control infections. See Abramson, D. J., A New Catheter Designed for Bladder Drainage and Urethral Irrigation; Amer. Surgeon, 34:436, 1968.
In addition, percutaneously inserted central venous catheters are widely used for food, fluid and drug therapy, as well as for monitoring, and, not surprisingly, catheter-related bacteremia or fungemia is the most frequent serious complication associated with such use. When catheter tubes are inserted directly into large blood vessels, septicemia or fungemia results in 3-7 percent of cases. Several devices are known in the background art for preventing catheter-related infection associated with surgically implanted central venous catheters. One such device incorporates a cuff that creates a mechanical barrier against infection by skin organisms. Such a device is disclosed by Dennis G. Maki et al, An Attachable Silver-Impregnated Cuff for Prevention of Infection with Central Venous Catheters: A Prospective Randomized Multicenter Trial, The American Journal of Medicine 85:307, (September) 1988. The device studied by Maki consists of an attachable cuff made of biodegradable collagen to which silver ion is cheleated. With the prior art device, the cuff is attached to a catheter immediately prior to insertion, and positioned approximately 0.25 to 0.75 centimeters below the surface of the skin upon catheter insertion. Inserting the prior art cuff below the surface of the skin, however, can cause irritation and require an enlargement of the insertion site than would otherwise be required. However, even with the prior art cuff, catheter infection with organisms or fungi from the catheter insertion site did occur as approximately 20 percent of the catheters in control groups showed one or more signs of inflammation at the insertion site. In addition, the prior art cuff experienced the undesirable tendency to extrude extracutaneously, either partially or totally.
Likewise, the use of surgical drain to convey infected material from body cavities, or, as is often the case, to drain non-infectious collections of bodily fluids that accumulate before or after surgery, experience similar problems resulting from bacteria or fungi colonizing the site of drain insertion.
Therefore, a need exists for a bacterial barrier for a catheter that can be attached to a conventional catheter and exteriorly positioned adjacent the catheter insertion site for preventing micro-organisms surrounding the insertion site from causing infection.